Healthy
Conditions
Brief summary
To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in breast milk of healthy lactating women after an oral administration of 10 mg once daily over a period of 8 days.
Interventions
DRUGBisacodyl
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women, age ≥18 and ≤50 years * Stopped with breast feeding their baby * Provided breast milk samples over a period of 10 days (including day -1) * Have been breast feeding for at least 14 days * Complied with the requirements of the protocol (e.g complete a diary) * Body Mass Index (BMI) ≤ 35 kg/m2 * Medically acceptable method of contraception \[i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive) or intrauterine device * Signed and dated a written informed consent prior to any study procedures study in accordance with Good Clinical practice (GCP) and the local legislation
Exclusion criteria
* Findings during medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance * Evidence of clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency, myocardial infarction, other known cardiovascular disease including hypertension * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, that may interfere with the safety of the subject * Surgery of the gastrointestinal tract (except appendectomy) in the last 2 years * Metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that would interfere with participation in the study * History of relevant orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections (e.g. HIV, Hepatitis) * Participated in another study with an investigational product within 1 month prior to enrolment into this study or during the study * Eating disorder * Hypersensitivity to bisacodyl, sodium picosulfate or any of the inactive ingredients * Any concomitant medication except for paracetamol or hormonal therapy. * Abnormal electrolyte values at the screening visit. The electrolyte values should be within the normal ranges * Alcohol abuse; subjects who report regular consumption of 40g/day = 5 units/day or more alcoholic drinks per day were excluded * Smoker (\>10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Drug abuse * Any laboratory value outside the reference range that is of clinical relevance * Mastitis * Less than 200 ml daily (24 hours) production of breast milk on day -1 * A positive pregnancy test at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 8 days | — |
| tmax (time from dosing to maximum measured concentration of the analyte in plasma) | up to 8 days | — |
| AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose) | up to 8 days | — |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 8 days | — |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz) | up to 8 days | — |
| %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) | up to 8 days | — |
| λz (terminal rate constant in plasma) | up to 8 days | — |
| t1/2 (terminal half-life of the analyte in plasma) | up to 8 days | — |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 8 days | — |
| CL/F (apparent clearance of the analyte in plasma following extravascular administration) | up to 8 days | — |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) | up to 8 days | — |
| Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) | up to 8 days | — |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 8 days | — |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 8 days | — |
| Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2) | up to 8 days | — |
| fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2) | up to 8 days | — |
| AUCτ,milk (area under the concentration-time curve of the analyte in milk over a uniform dosing interval τ after administration of the first dose) | up to 8 days | — |
| milk to plasma ratio (AUCτ,milk / AUCτ) | up to 8 days | — |
| estimated daily infant dosage | up to 8 days | (milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day) |
| Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | up to 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | up to 8 days |
| Number of patients with abnormal laboratory findings | up to 8 days |
| Number of patients with abnormal electrocardiogram findings | up to 8 days |
| Number of patients with clinically significant changes in vital signs | up to 8 days |
| Number of bowel movements | up to 8 days |
Outcome results
None listed